ICH Advances Revised Guideline on Elemental Impurities

Regulatory NewsRegulatory News
| 26 March 2019 | By Ana Mulero 

The internationally harmonized guideline for a risk-based approach on assessing and controlling elemental impurities in drug products entered the final implementation phase.

ICH Q3D(R1) Guideline for Elemental Impurities, developed via the International Council for Harmonisation (ICH), reached the fourth out of five steps in ICH’s process of regulatory harmonization last week, moving toward implementation of the revised guideline. The guideline was first recommended for adoption by the ICH member regulatory authorities in 2014 but was re-released for public consultation in May 2018 due to the revision of the Permitted Daily Exposure (PDE) level for Cadmium by inhalation. 

The Q3D(R1) quality guideline establishes a harmonized platform intended to limit elemental impurities in drug products by conducting assessments and employing a control strategy based on the risk management principles previously set forth via ICH Q9: Quality Risk Management. It also defines the PDEs for 24 elemental impurities for drug products administered orally, parentally and by inhalation.

The revised Cadmium inhalation PDE is 3.4 versus the 1.7 PDE ICH recommended for adoption in 2014.

Earlier adoption and regional implementation of the Q3D(R1) ranged between 2014 and 2016 among the ICH regulatory bodies, which include the European Medicines Agency, Japan’s Ministry of Health, Labour and Welfare, the US Food and Drug Administration (FDA), Health Canada and Swissmedic.

FDA finalized its addendum to the ICH elemental impurities guidelines last August. With the July 2018 draft version of this FDA guidance document, the agency had explained that the revision to the previous Cadmium inhalation PDE was needed to “correct a calculation error” and it had been revised “based on a modifying factor approach that is consistent with the oral and parenteral PDE calculations.”

ICH Q3D(R1) Guideline for Elemental Impurities


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